1.0 OBJECTIVEThe objective of this procedure to avoid the errors inherent in performance of any analysis, Good laboratory practices shall be followed.
2.0 SCOPEThis SOP is to provide guidelines for Good Laboratory practice.
3.0 RESPONSIBILITYOfficer/ Executive - Quality Control
4.0 ACCOUNTABILITYManager – Quality Control
5.0 PROCEDURE5.1 Procedure
5.1.1 While performing any analysis always follow respective standard operating procedure.
5.1.2 Use only pure (AR / GR grade) material for standardization.
5.1.3 Use calibrated volumetric glassware only when accurate dilutions are required.
5.1.4 Ensure that the temperature during dilution, at the time of volumetric measurement and standardization is maintained i. e. at about 25°C.
5.1.5 Rinse the burette or other vessel used to collect the volumetric solution with the solution to be standardized.
5.1.6 While dilution always add concentrated acid slowly to the water, and never add water to acid.
5.1.7 Handle the chemicals and solvents in a way to avoid spillage on the working bench and the floor.
5.1.8 In the case of any spillage immediately clean the affected area, according to the type of spillage.
5.1.9 Wear a full-seal goggles and safety mask while handling concentrated acids and bases.
5.1.10 Never try and adjust the pH of a solution in a narrow-neck container. Always use a beaker.
5.1.11 Never stick a spatula into a container of a solid reagent. Always roll the container to deliver the reagent in a controlled manner to the receiving beaker.
5.1.12 Never return unused reagent to the reagent container. Contamination of the whole reagent supply is more costly than the small amount of reagent discarded.
5.1.13 Use water for injection, unless otherwise specified, for preparation and standardization of solution.
5.1.14 Use water for injection for the preparation of buffer solution, indicator solution, standard solution unless otherwise specified.5.1.15 Standardize the volumetric solution with that method only which is used for endpoint determination.
5.1.16 Store the light-sensitive solution in the light resistant (amber colored) containers only.
5.1.17 Label all the reagents for Name, strength, prepared by & on and shelf life.
5.1.18 While performing titration in case of colorless solutions in the burette, consider the lower meniscus as the reading. In case of colored solutions consider upper meniscus.
5.1.19 Always fill burette taking it away from the stand in to the hand and using a glass funnel. Adjust the reading to zero before starting titration.
5.1.20 Use approximately 0.1 ml of indicator, during titration or standardization, unless otherwise specified.
5.1.21 Never use broken glass-wares and in case of iodometric titration use iodine flask.
5.1.22 Store toxic and flammable chemicals in the separate area under lock and key.
5.1.23 Store all the reference standards and stock of working standards in their Specified area.
5.1.24 Working standards in use are to be stored in the desiccator provided. And the bottles are sealed immediately after their use.
5.1.25 Never leave any chemical reaction taking place on the gas i.e. boiling, distillation, refluxing unattended.
5.1.26 While boiling anything, keep the container opened, if not refluxing.
5.1.27 Check the LPG cylinder and pressure tubing for any damage or leakage; change the tubing if damage or leakage is found.
5.1.28 Always close LPG valve first and then put off the compressor while working with them, there is a chance of explosion when compressor is closed first.
5.1.29 Always keep the burner OFF while mopping the LAF bench.
5.1.30 After completion of any microbiological work, put on the UV light.
5.1.31 Never look directly into the UV light.
5.1.32 For analysis always use calibrated instruments.
5.1.33 If instrument / equipment found damaged, do not use it and consult Q. C. Manager / executive to get it repaired or changed.
5.1.34 While cleaning any electrode of either pH meter or conductivity meter, clean them with water for injection and wipe off with the help of a tissue paper gently.5.1.35 Never rub the electrode and keep all the electrodes dipped constantly on the water for injection.
6.0 ABBREVIATIONS6.1 SOP - Standard Operating Procedure
6.2 QC - Quality Control
6.3 LAF - Laminar Air Flow
6.4 LPG - Liquid Petroleum Gas
6.5 UV - Ultra Violet6.6 AR - Analytical Grade Reagent
6.7 GR - General Reagent
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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